510(k) · Cleared
Recalled · Class II · 2023Volista 400; Volista 600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet S.A.S. · FTD Lamp, Surgical
Cleared on May 8, 2013 as substantially equivalent to K070442 (Maquet S.A., 2007) and 1 other predicate after a 70-day review. Its family tree reaches back 4 generations to 1991. It has been recalled 19 times.
- Decided
- May 8, 2013
- Review
- 70 days
- Class
- Class II
- Product code
- FTD
- Recalls
- 19
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904965 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK904965 Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group · 1991
- 3 generations backK040735 Alm X'ten (X10) Surgical Light SystemAlm S.A. · 2004 · Recalled
- 2 generations backK070442 Powerled Surgical Light SystemMaquet S.A. · 2007 · Recalled
- 1 generation backK113679 Lucea Led Surgical Light SystemMaquet S.A.S. · 2012 · Recalled
- This deviceK130513 Volista 400; Volista 600Maquet S.A.S. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904965 | Shampaine 1000 Series Angenieux AX-14 Duo,AX-4 | Smith & Nephew Equipment Group | 1991 | — |
| −3 | K040735 | Alm X'ten (X10) Surgical Light System | Alm S.A. | 2004 | 6 |
| −2 | K070442 | Powerled Surgical Light System | Maquet S.A. | 2007 | 3 |
| −1 | K113679 | Lucea Led Surgical Light System | Maquet S.A.S. | 2012 | 1 |
| 0 (this device) | K130513 | Volista 400; Volista 600 | Maquet S.A.S. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070442 | Powerled Surgical Light SystemSummary page 1…ice classification Class 11,acording to regulation number 21 CER 878.4580 Predicate Device identification " MAQUET POWERLEDTM Surgical Light System - 510(k) No. K070442 * MAQUET LUCEA LED® Surgical Light System - 510(k) No. Ki113679… | 2007 |
| * | K113679 | Lucea Led Surgical Light SystemSummary page 1…R 878.4580 Predicate Device identification " MAQUET POWERLEDTM Surgical Light System - 510(k) No. K070442 * MAQUET LUCEA LED® Surgical Light System - 510(k) No. Ki113679 Page 1 of 4 MAQUET S.A.S. FDA 51… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2023 | Class II | Z-0758-2024 | Equipment maintenance | A potential for a light system to fall in the operating room. |
| May 6, 2022 | Class II | Z-1308-2022 | Process change control | Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the… |
| May 28, 2019 | Class II | Z-1860-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1862-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1852-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1861-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1858-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1857-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1853-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1856-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1859-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1854-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1864-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1863-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| May 28, 2019 | Class II | Z-1855-2019 | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection |
| Jun 14, 2018 | Class II | Z-2502-2018 | Process control | Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket… |
| Apr 19, 2018 | Class II | Z-1937-2018 | Device Design | Potential keypad failure on VOLISTA StandOP Surgical Lights. |
| Feb 7, 2018 | Class II | Z-1349-2018 | Component design/selection | The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder… |
| May 29, 2015 | Class II | Z-1990-2015 | Device Design | Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted… |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 5 of the 6 ancestors have a recall of any class.
- 6 other devices also cite its predicate K070442.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130513: Volista 400; Volista 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130513
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026